A Prospective, Interventional, Randomized, Parallel, Double blind Controlled Clinical Study to evaluate the Efficacy & Safety of Co-Ex Cough Syrup in the treatment of acute upper respiratory tract infection.

Not Applicable

Completed

• Conditions: Health Condition 1: J060- Acute laryngopharyngitis

• Registration Number: CTRI/2021/03/031856
• Lead Sponsor: BHARGAVA PHYTOLAB PVT LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-16
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1.Male & Female Volunteers, with age >= 12 years

2.Score greater than or equal to 3 points on the cough severity score

3.Subjects who have not participated in a similar investigation in the past four weeks.

4.Subjects able to provide informed consent.

5.Subject is willing and able to comply with all trial requirements

Exclusion Criteria

1.Pregnancy or risk of pregnancy.

2.Lactation mother

3.Fever above 38º C.

4.Subjects who are on ACE inhibitor drugs

5.Subjects having GERD

6.Subjects with bacterial infections of the upper respiratory tract.

7.Any pathology or past medical condition that can interfere with this protocol

8.Presence of the following diseases (like cholangitis, pancreatitis, etc.) or uncontrolled severe organ disorders

9.Severe neurological or psychological disorders or a history of alcohol or drug abuse.

10.History of allergic reaction to the medications used in the study

11.Use of other investigational drugs within 30 days prior to the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Significant relief from cough using Severity cough score from baseline to visit 3. <br/ ><br>2.Significant Reduction in cough using Severity cough score from baseline to EOT <br/ ><br>3.Duration of RTIâ??s as assessed from subject diary <br/ ><br>Timepoint: Baseline, Day 3, Day 5, Day 7 and day 14

Secondary Outcome Measures

Name	Time	Method
1.Assessment for safety and tolerability of cough syrup will be evaluated on the basis of subjective symptoms and opinions expressed by the subjects. <br/ ><br>2.Changes in total IgG, IgM &IgE from baseline to EOT. <br/ ><br>3.Assessment of safety investigational product: <br/ ><br>4.Adverse event <br/ ><br>5.Biomarker of systemic safety <br/ ><br>a.Hematological â?? Haemogram <br/ ><br>b.Hepatic - SGOT, SGPT <br/ ><br>Timepoint: Baseline, Day 3, Day 5, Day 7 and day 14